The process manufacturing and automaton literature abounds with numerous success stories of Level 3 to 4 integrations that leverage the ANSI/ISA-95 standard to provide interoperability between MES and ERP systems.

However, the literature provides little discussion regarding connectivity of Level 3 systems, such as MES, to Level 2 & 1 process control systems, particularly in the area of biotech and pharmaceutical manufacturing. The lack of discussion on this topic can likely be attributed to the dominance of batch control systems integrated with DCS or SCADA/PLC platforms used in bulk bio/pharmaceutical manufacturing. Many of the MES successes in these industries have occurred in weigh-and-dispense applications that are typically manual activities. Recent initiatives have introduced MES into more highly automated batch control architectures. Notably, these architectures are often separate systems and primarily focus on the MES paper-on-glass technology as a point of integration to the batch control system.

This paper discusses the advantages of interoperability between MES and batch control systems which execute recipe procedures represented by unit procedures, operations, and phases as defined in ANSI/ISA-88. It presents typical data structures that can be directly exchanged between the two systems while they execute concurrently to leverage the most effective features of each system. At the center of this application is the ability of a batch control system to carry out recipe procedures under the direction of an MES. In the application, equipment phases in the process control device interface with the MES to exchange material tracking data, access equipment resource information, and request electronic work-instructions. Presented are application examples from a new bulk biotech manufacturing facility currently under commissioning and qualification in Northern California.